This document specifies symbols used to express information supplied for a medical device.

NOTE Numbers given in square brackets throughout the document refer to the Bibliography. Symbols added during the revision of this document were placed at the end of the pertinent section of Table 1 to preserve the numbering of existing symbols and facilitate easy referencing of existing symbols in other documents. “Notes to entry” used in Clause 3 provide additional information that supplements the terminological data and can contain provisions relating to the use of a term. Information marked as “NOTE” is intended to assist the understanding or use of the document. “must” indicates an external constraint that is not a requirement of the document. “can” indicates a possibility or a capability In this document, the following verbal forms are used: Terms defined in Clause 3 are shown in italic type throughout the document. In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. It can also be used by consumers or end users of medical devices who draw their supplies from a number of sources and can have varied language capabilities. These symbols allow for a consistent portrayal of information. This document is intended to be used by manufacturers of medical devices who market products in countries where there are specific language requirements. The symbols included in this document have been published in ISO 7000, ISO 7001, IEC 60417 or have been subjected to a formal symbol validation process. This document does not specify the information that needs to be provided, but does specify internationally recognized symbols for the provision of this specific information.

For simplicity and to avoid translation of text, this information can be provided as symbols that have a specific meaning. Medical device manufacturers and others in the supply chain must provide specific information on the medical device itself, as part of the packaging, or in the accompanying information. information about European regulations has been moved to informative notes throughout. expansion of the examples given in Annex A inclusion of defined terms from ISO 20417, ISO 13485 and ISO 14971 deletion of the defined term “labelling” addition of 5 symbols previously published in ISO 7000, ISO 7001 and IEC 60417 addition of 20 symbols that were validated as per ISO 15223-2

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